The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices. Officials say the move is intended to speed innovation while maintaining ...

Marty Makary, the US Food and Drug Administration (FDA) Commissioner, said wearable devices, like Apple Watch and Whoop, which provide non-medical-grade information, will not be subject to FDA ...

Dec 3 : Niche fitness-tracking firms such as WHOOP are coming under increased regulatory scrutiny as technological advances blur the lines between wearable and medical devices, exposing them to higher ...

Like many in the medtech industry, I was initially optimistic when FDA announced its revised guidance on wearable wellness devices. For years, the industry has called for clearer, more predictable ...

The FDA exempts non-medical grade wearables from regulation, focusing on AI and digital health clarity. Guidance document outlines compliance for low-risk wellness products promoting healthy ...

The FDA will not regulate wearable devices that provide nonmedical-grade health information, a move aimed at giving technology companies clearer guidance as AI-driven health tools proliferate, Fox ...

Wearable devices and digital apps that are available to consumers are emerging as potential tools in neurological care. These include smart watches and fitness trackers to monitor heart rate, physical ...

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

Dec 3 (Reuters) - Niche fitness-tracking firms such as WHOOP are coming under increased regulatory scrutiny as technological advances blur the lines between wearable and medical devices, exposing them ...